#safetyandperformance #MDR #IVDR #acceptancecriteria #clinicalevaluation #CER
Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will present strategies for the verification of device safety and performance in the clinical evaluation. This presentation should help you with identifying meaningful safety and performance measures for the clinical evaluation and with defining parameters to determine the acceptability of benefit-risk.
Have more questions? Reach out to us at info@criterionedge.com.
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///Key Takeaways///
Based on the state-of-the-art:
• Identify meaningful safety and performance endpoints (measures/objectives)
• Demonstrate that safety and performance objectives are appropriate and clinically relevant
• Specify acceptance criteria that are used to determine the acceptability of benefit-risk
///Who Should Watch///
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs. We encourage professionals from the IVD industry to watch as well, as the content is also relevant to IVDR requirements, which align closely with MDR.
///Speaker///
Laurie Mitchell
Founder/President of Criterion Edge, a global regulatory writing services firm serving the medical device, pharmaceutical, and biotech industries. She has over 25 years experience in medical writing, pharmacovigilance management, and regulatory reporting. Prior to Criterion Edge, Laurie founded Mitchell Research Group, a successful site management organization, and acted as a Clinical Safety consultant for Abbott Vascular for almost a decade. Laurie brings extensive experience creating and training Data Safety Monitoring Boards and Clinical Event Committees and working with global cross-functional teams. Having worked for three of the four major medical device sponsors, she maintains expertise in many therapeutic areas. She holds a BS in Nursing and an MS as a Cardiopulmonary Clinical Nurse Specialist from UCLA.
